A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032277
• Other study ID #: M14-011
• Secondary ID: 2013-002377-21
• Status: Completed
• Phase: Phase 3
• Start date: April 2, 2014
• Est. completion date: November 12, 2020

Study information

• Verified date: January 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: November 12, 2020
• Est. primary completion date: March 18, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.

2. Documented Breast Cancer Gene (BRCA) germline mutation testing.

3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.

4. ECOG Performance status of 0 to 1.

5. Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization.

Exclusion Criteria:

1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.

2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.

3. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.

4. A history of seizure within 12 months prior to study entry.

5. Pre-existing neuropathy from any cause in excess of Grade 1.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Cyclophosphamide
Cyclophosphamide
• Placebo
Placebo for Carboplatin
• Doxorubicin
Doxorubicin
• Paclitaxel
Paclitaxel
• Carboplatin
Carboplatin
• Veliparib
Veliparib
• Placebo
Placebo for Veliparib

Locations

Country	Name	City	State
Australia	Cabrini Health /ID# 120236	Malvern	Victoria
Australia	Fiona Stanley Hospital /ID# 120716	Murdoch	Western Australia
Australia	St. John of God Hosp - Murdoch /ID# 131788	Murdoch	Western Australia
Australia	Royal Melbourne Hospital /ID# 127717	Parkville	Victoria
Australia	Western Health Sunshine Hosp. /ID# 120715	St. Albans	Victoria
Australia	St. John of God Subiaco Hosp /ID# 120717	Subiaco	Western Australia
Australia	The Tweed Hospital /ID# 120235	Tweed Heads	New South Wales
Belgium	CHU Brugmann /ID# 120376	Brussels
Belgium	Grand Hôpital de Charleroi /ID# 116678	Charleroi	Hainaut
Belgium	UZ Antwerp /ID# 120720	Edegem
Belgium	AZ Groeninge /ID# 120718	Kortrijk
Belgium	CHU UCL Namur /ID# 116677	Namur
Belgium	Cliniques Universitaires Saint Luc /ID# 120719	Woluwe-Saint-Lambert	Bruxelles-Capitale
Canada	Jewish General Hospital /ID# 141629	Montreal	Quebec
Canada	CHUM - Notre-Dame Hospital /ID# 141694	Montréal	Quebec
Canada	CHUQ-Hospital St. Sacrement /ID# 141619	Quebec City	Quebec
Canada	Sunnybrook Health Sciences Ctr /ID# 123312	Toronto	Ontario
Czechia	Masarykuv onkologikcy ustav /ID# 120726	Brno
Czechia	FN Hradec Kralove /ID# 120596	Hradec Kralove
Czechia	Fakultni Nemocnice Olomouc /ID# 120725	Olomouc	Olomoucky Kraj
France	Jean Perrin Centre /ID# 125277	Clermont Ferrand
France	Centre Oscar Lambret /ID# 119958	Lille	Hauts-de-France
France	Centre Leon Berard /ID# 120740	Lyon CEDEX 08	Rhone
France	Hosp European, Georges Pompid /ID# 120736	Paris
France	Institut Curie /ID# 116679	Paris CEDEX 05	Ile-de-France
France	Hopital Rene Huguenin /ID# 120729	Saint-cloud
France	Hopital Universitaire Purpan /ID# 120731	Toulouse	Haute-Garonne
Germany	Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 133472	Augsburg
Germany	Helios Klinikum Berlin Buch /ID# 133465	Berlin
Germany	Studiengesellschaft Onk Bielef /ID# 133471	Bielefeld
Germany	Klinikum Bremen Mitte gGmbH /ID# 132875	Bremen
Germany	St. Johannes Hospital /ID# 133478	Dortmund
Germany	Kliniken Esslingen /ID# 133475	Esslingen
Germany	Klinikum Frankfurt Hoechst /ID# 145301	Frankfurt
Germany	Wilke/Wagner/Petzoldt, Fuerth /ID# 133481	Fürth
Germany	Evangelisches Krankenhaus /ID# 133457	Gelsenkirchen
Germany	Elisabeth Krankenhaus /ID# 133461	Kassel
Germany	Universitaetsklinikum Schleswig-Holstein /ID# 133454	Kiel	Schleswig-Holstein
Germany	St. Vincenz Krankenhaus /ID# 133466	Limburg
Germany	Klinikum recht der Isar der TU /ID# 133449	Munich
Germany	Onk Zentrum am Rotkreuz /ID# 133482	Munich
Germany	Sana Klinikum Offenbach /ID# 133455	Offenbach
Germany	Leopoldina-Krankenhaus /ID# 133484	Schweinfurt
Germany	Johanniter-Krankenhaus Genthin /ID# 133463	Stendal
Germany	Universitaetsklinikum Ulm /ID# 133453	Ulm	Thueringen
Germany	St. Josefs-Hospital /ID# 133464	Wiesbaden
Germany	Marienhospital Witten /ID# 133470	Witten
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont /ID# 120834	Budapest
Hungary	National Institute of Oncology /ID# 120828	Budapest
Hungary	Uzsoki Utcai Korhaz /ID# 120825	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont /ID# 116681	Debrecen
Hungary	Petz Aladar Megyei Oktato Korh /ID# 120835	Gyor
Hungary	Bacs-Kiskun Megyei Korhaz /ID# 120833	Kecskemét
Hungary	BAZ Megyei E.O. Korhaz /ID# 122215	Miskolc
Hungary	University of Szeged /ID# 120823	Szeged
Hungary	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 120818	Szolnok
Italy	A.O.U. Policlinico S.Orsola-Malpighi /ID# 122855	Bologna	Emilia-Romagna
Italy	Misericordia General Hospital /ID# 119536	Grosseto
Italy	IRCCS-I.R.S.T. srl Meldola /ID# 120255	Meldola
Italy	Istituto Europeo di Oncologia /ID# 120845	Milan
Italy	IRCCS Fondazione Salva Maugeri /ID# 120848	Pavia
Korea, Republic of	Kyungpook National University Chilgok Hospital /ID# 118855	Daegu	Seoul Teugbyeolsi
Korea, Republic of	National Cancer Center /ID# 119525	Goyang	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 116696	Seoul
Korea, Republic of	Korea University Anam Hospital /ID# 118857	Seoul
Korea, Republic of	Samsung Medical Center /ID# 119276	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital /ID# 116698	Seoul
Korea, Republic of	Severance Hospital /ID# 116699	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Ajou University Hospital /ID# 118856	Suwon-si	Gyeonggido
Netherlands	Vrije Universiteit Medisch Centrum /ID# 126302	Amsterdam
Russian Federation	archangel Clinical Oncology /ID# 120935	Arkhangelsk
Russian Federation	Kursk Regional Oncology Dispen /ID# 116688	Kursk	Tatarstan, Respublika
Russian Federation	Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 120944	Moscow	Moskva
Russian Federation	Medical Radiological Res Ctr /ID# 124017	Obninsk
Russian Federation	Pyatigorsk Oncology Dispensary /ID# 120945	Pyatigorsk
Russian Federation	Birch A Healthcare /ID# 116695	St. Petersburg
Russian Federation	Leningrad Reg Onc Dispensery /ID# 120938	St. Petersburg
Spain	Hospital Universitario A Coruña - CHUAC /ID# 135108	A Coruña	A Coruna
Spain	Hospital General Universitario Alicante /ID# 135115	Alicante
Spain	Hospital Universitario Germans Trias i Pujol /ID# 135112	Badalona	Barcelona
Spain	Hospital Parc de Salut del Mar /ID# 135110	Barcelona
Spain	Hospital Santa Creu i Sant Pau /ID# 145400	Barcelona
Spain	Hospital Universitario Arnau de Vilanova de Lleida /ID# 120979	Lleida
Spain	Hospital Clinico Universitario San Carlos /ID# 119959	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 135113	Madrid
Spain	Hospital Universitario Virgen del Rocio /ID# 135114	Sevilla
Spain	Fundacion Instituto Valenciano Oncologia IVO /ID# 135116	Valencia
Spain	Hospital Clinico Universitario de Valencia /ID# 123076	Valencia
Spain	Hospital General Universitario de Valencia /ID# 135111	Valencia
Spain	Hospital Universitario Miguel Servet /ID# 119195	Zaragoza
Taiwan	Changhua Christian Hospital /ID# 119085	Changhua County
Taiwan	Chi Mei Hospital - Liouying /ID# 120982	Tainan City
Taiwan	National Taiwan Univ Hosp /ID# 122895	Taipei City	Taipei
United Kingdom	Univ Hosp Bristol NHS Foundati /ID# 120989	Bristol
United Kingdom	Charing Cross Hospital /ID# 120990	London
United Kingdom	Nottingham Univ Hospitals NHS /ID# 122218	Nottingham
United Kingdom	Royal Stoke Univ Hospital /ID# 120984	Stoke on Trent
United States	Lehigh Valley Health Network /ID# 133372	Allentown	Pennsylvania
United States	Hope Womens Cancer Centers /ID# 119179	Asheville	North Carolina
United States	Univ Maryland School Medicine /ID# 119235	Baltimore	Maryland
United States	Texas Oncology - Bedford /ID# 126135	Bedford	Texas
United States	Univ NC Chapel Hill /ID# 132893	Chapel Hill	North Carolina
United States	Univ NC Chapel Hill /ID# 147695	Chapel Hill	North Carolina
United States	University of Virginia /ID# 122975	Charlottesville	Virginia
United States	Northwestern University Feinberg School of Medicine /ID# 133848	Chicago	Illinois
United States	University of Chicago DCAM /ID# 120467	Chicago	Illinois
United States	University of Illinois - Chicago /ID# 134329	Chicago	Illinois
United States	Oncology Hematology Care, Inc - Blue Ash /ID# 120478	Cincinnati	Ohio
United States	Cleveland Clinic Main Campus /ID# 126378	Cleveland	Ohio
United States	Fairview Hospital /ID# 141626	Cleveland	Ohio
United States	University Hospitals Case Medical Center /ID# 141691	Cleveland	Ohio
United States	The Ohio State University /ID# 141587	Columbus	Ohio
United States	Texas Oncology - Medical City Dallas /ID# 126140	Dallas	Texas
United States	Texas Oncology - Medical City Dallas /ID# 126141	Dallas	Texas
United States	UT Southwestern Medical Center /ID# 133849	Dallas	Texas
United States	Sanford Roger Maris Cancer Cen /ID# 132394	Fargo	North Dakota
United States	Florida Cancer Specialists - Fort Myers /ID# 121835	Fort Myers	Florida
United States	Florida Cancer Specialists - Fort Myers /ID# 126379	Fort Myers	Florida
United States	The Ctr for Cancer and Blood D /ID# 120479	Fort Worth	Texas
United States	Texas Oncology - Memorial City /ID# 126139	Houston	Texas
United States	Community Rgnal Cancer Care N /ID# 120456	Indianapolis	Indiana
United States	Indiana Univ School Medicine /ID# 118215	Indianapolis	Indiana
United States	Mayo Clinic /ID# 132349	Jacksonville	Florida
United States	St. Lukes Cancer Institute /ID# 118775	Kansas City	Missouri
United States	Horizon Oncology Research Center /ID# 116815	Lafayette	Indiana
United States	Comprehensive Cancer Ctrs Neva /ID# 126136	Las Vegas	Nevada
United States	Usc /Id# 123310	Los Angeles	California
United States	Univ of Wisconsin Hosp/Clinics /ID# 120457	Madison	Wisconsin
United States	Solinksy Center for Cancer Care /ID# 131970	Manchester	New Hampshire
United States	Loyola University Medical Ctr /ID# 120455	Maywood	Illinois
United States	Miami Cancer Institute - Baptist Health South Florida /ID# 126145	Miami	Florida
United States	Mount Sinai Comp Cancer Ctr /ID# 133008	Miami	Florida
United States	Minnesota Oncology Hematology, PA /ID# 126144	Minneapolis	Minnesota
United States	Tennessee Oncology, PLLC /ID# 124566	Nashville	Tennessee
United States	Rutgers Cancer Institute of NJ /ID# 120477	New Brunswick	New Jersey
United States	Columbia Univ Medical Center /ID# 141588	New York	New York
United States	Christiana Care Health Service /ID# 137823	Newark	Delaware
United States	UF Health Cancer Center /ID# 141589	Orlando	Florida
United States	Texas Oncology - Plano East /ID# 126143	Plano	Texas
United States	Women and Infants Hospital /ID# 123476	Providence	Rhode Island
United States	Virginia Commonwealth Univ /ID# 141586	Richmond	Virginia
United States	OSF St. Anthony Medical Center /ID# 139424	Rockford	Illinois
United States	Pacific Cancer Care /ID# 120476	Salinas	California
United States	University of Utah /ID# 118677	Salt Lake City	Utah
United States	Sharp Memorial Hospital /ID# 119861	San Diego	California
United States	Guthrie Medical Group, PC /ID# 124397	Sayre	Pennsylvania
United States	Mayo Clinic - Scottsdale /ID# 139932	Scottsdale	Arizona
United States	Scottsdale Healthcare /ID# 120473	Scottsdale	Arizona
United States	Avera Cancer Institute /ID# 120466	Sioux Falls	South Dakota
United States	Stanford University School of Med /ID# 130316	Stanford	California
United States	Moffitt Cancer Center /ID# 124063	Tampa	Florida
United States	Arizona Oncology Associates, PC-HOPE /ID# 126137	Tucson	Arizona
United States	Texas Oncology - Tyler /ID# 126142	Tyler	Texas
United States	Virginia Oncology Associates /ID# 127260	Virginia Beach	Virginia
United States	Cedars-Sinai Medical Center - West Hollywood /ID# 137275	West Hollywood	California
United States	Cancer Center of Kansas /ID# 134720	Wichita	Kansas
United States	Novant Health Oncology Special /ID# 139890	Winston-Salem	North Carolina
United States	St. Joseph Mercy Hospital /ID# 135875	Ypsilanti	Michigan

Sponsors (5)

Lead Sponsor	Collaborator
AbbVie	German Breast Group, Grupo Español de Investigación del Cáncer de Mama, NSABP Foundation Inc, US Oncology Research

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Netherlands,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response (pCR).	Pathological complete response (pCR) in the breast tissue and the lymph node tissue will be assessed upon completion of pre-operative systemic therapy and definitive surgery.	At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).
Secondary	Event Free Survival (EFS)	EFS will be defined as the time from random assignment to documentation of the first of the following events: discontinuation of study therapy due to protocol-defined progression prior to surgery; local, regional, or distant recurrence of breast cancer following curative surgery; a new breast cancer; another new onset malignancy; or death as a result of any cause.	Up to 4 years from the date of definitive surgery.
Secondary	Overall Survival (OS)	OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death.	Up to 4 years from the date of definitive surgery.
Secondary	Rate of eligibility for breast conservation after therapy (BCR).	Whether a subject is eligible for breast conserving surgery for whom mastectomy was planned at diagnosis will be determined by the subject's surgeon prior to chemotherapy and after completion of chemotherapy.	At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).